CancerPhase 1NCT01495663
Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned
A Phase 1 study testing I-131-CLR1404 in people with Cancer, run by Cellectar Biosciences, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- I-131-CLR1404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory advanced solid malignancy or choice not to pursue standard treatment. Tumor types allowed: non-small cell lung, triple negative breast, soft tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian cancer
- ≥ 1 lesion that qualifies as a "target lesion" based on RECIST 1.1
- Ambulatory w/ECOG performance status 0 to 2 and estimated life expectancy ≥ 4 mo.
- 18 years or older
- Judged by Investigator to have initiative and means to be compliant with protocol and w/n geographical proximity to make required study visits
- Ability to read, understand and provide written informed consent for initiation of any study related procedures (subject or legal representative)
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- Brain metastasis acceptable if clinical condition stable ≥ 1 mo. Subjects with brain metastasis requiring steroids must have been on a stable or tapering dose of corticosteroids ≥ 1 mo. prior to enrollment
- Negative serum pregnancy test w/n 24 hours of enrollment (Female subjects of childbearing potential)
- Agreement to use effective contraception method (oral contraceptives, double-barrier methods, intrauterine device, Norplant, Depo-Provera) during study and 90 days following last dose
Who cannot join
- Subject or physician plans concomitant chemotherapy, therapeutic radiation and/or biological treatment for cancer including immunotherapy while on study. Localized palliative radiation therapy for bone pain allowed if clinically indicated. Ongoing hormonal therapy may be continued
- Received > 3 previous cytotoxic chemotherapy regimens
- Received > 25% of total bone marrow irradiated, total body or hemi-body irradiation or prior radioisotope therapy (except for benign thyroid disease)
- Diffuse lung disease or interstitial spread of carcinoma
- Prior radiation therapy or chemotherapy w/n 4 weeks of study start
- Extradural tumor in contact with spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
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- Other active medical condition or organ disease that may compromise safety or interfere with safety and/or outcome evaluation of study drug
- Laboratory abnormalities, including but not limited to: WBC < 3000/uL, Absolute neutrophil count < 1500/uL, Platelets < 150,000/uL, Hemoglobin ≤ 9.0 gm/dL, Total bilirubin > 1.5 x upper limit of normal for age, SGOT or SGPT > 3 x upper limit of normal for age if no liver metastases or > 5 x upper limit of normal for age in the presence of liver metastases, Serum creatinine > 1.5 x upper limit of normal for age, INR ≥ 2.0, 2+ proteinuria or casts indicative of intrinsic renal disease
- Treatment with investigational drug, investigational biologic, or investigational therapeutic device w/n 28 days of initiating study treatment
- Received severely marrow toxic drugs (eg nitrosoureas, mitomycin)
- Received blood transfusions or hematopoietic growth factor therapy w/n 30 days of study start
- Received prior stem cell transplantation
- Clinically significant cardiac co-morbidities including congestive heart failure (New York Heart Association class III-IV heart disease), left ventricular ejection fraction < 40%, unstable angina pectoris, serious cardiac arrhythmia requiring medication or pacemaker, myocardial infarction within past 6 months
- Concurrent or recent (w/n 1 month) use of thrombolytic agents or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Therapy with low-molecular weight heparin is acceptable as long as INR < 2.0
- Uncontrolled hypertension as defined by systolic blood pressure > 150 mm/Hg, diastolic blood pressure > 100 mm/Hg or uncontrolled diabetes that would compromise subject safety or interfere with safety and/or outcome evaluation of study drug
- Grade II-IV peripheral vascular disease or peripheral vascular surgery w/n past year
- Major surgery w/n 4 wks. of enrollment
- Poor venous access and unable to receive study drug into a peripheral venous catheter
- Significant traumatic injury w/n past 4 wks.
- Ongoing or active infection requiring antibiotics or with fever >38.1º C (>101º F) w/n 3 days of first scheduled day of dosing
- Receiving concurrent hemodialysis or peritoneal dialysis
- Known positive for HIV, Hepatitis C (active, previously treated or both) or is Hepatitis B core antigen positive
- Pregnant or lactating
- Hospitalized
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope National Medical Center
Duarte, California, 91010
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113
About this study
Official title: A Phase 1, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects With Relapsed or Refractory Advanced Solid Malignancies
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase clinical development.
Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.
All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to injection of the dosimetric dose, and continuing for 14 days after the administration of the therapy dose.
- Conditions
- Cancer
- Being tested
- I-131-CLR1404
- Keywords
- refractory, relapsed, non-small cell lung cancer, triple-negative breast cancer, soft tissue sarcoma, colorectal cancer, esophageal cancer, prostate cancer, ovarian cancer
- Medical subject headings
- Neoplasms, Recurrence, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Sarcoma, Colorectal Neoplasms, Esophageal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-131-CLR1404Drug
Also called 18-(p-[I-131]-iodophenyl)octadecyl phosphocholine
Description:
- Dosimetry: IV, 5 mCi, single dose, 6-day duration
- Therapy: IV, starting dose level of 12.5 mCi/m2, single dose, 56-day duration with follow up to one year
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Other | I-131-CLR1404 Receives: Drug: I-131-CLR1404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies
Largest administered dose with at most a 20% dose limiting toxicity rate
Measured: Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)
Secondary outcomes (4)
Expansion of the safety profile of I-131-CLR1404
Assesment by physical examination, vital signs, ECG, laboratory changes over time, and adverse events
Measured: Pre-infusion and 6 days after dosimetry infusion; weekly until 56 days after therapy infusion and then monthly for one year
Expansion of the pharmacokinetic profile of I-131-CLR1404
Determination of the following pharmacokinetic parameters of I-131-CLR1404:
- Area under the plasma concentration versus time curve (AUC)
- Maximum (peak) plasma concentration (Cmax)
- Time required to reduce the plasma concentration to one half its initial value (t1/2)
- Volume of distribution (Vd)
- Clearance of the drug from plasma (Cl)
Measured: Pre-infusion and 144 hours post-dosimetry infusion; pre-infusion, 5, 15, 60 minutes, 5, 24, 72 hours, 6, 14, 21, 28, 35, 42, 49 and 56 days post-therapy infusion
Preliminary antitumor activity of I-131-CLR1404
CT imaging (response and progression will be evaluated using RECIST 1.1) and tumor marker evaluation in subjects with applicable tumors (performed at screening, 28 and 56 days post-therapy infusion)
Measured: Baseline at screening, 56 days post-therapy infusion, every 2 months in follow-up period up to one year
Tumor dosimetry of I-131-CLR1404 in a subset of subjects with non-hepatic lesions measuring at least 2 cm in one dimension
SPECT or SPECT/CT
Measured: 72 hours, 6, 14, and 21 days post-therapy infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellectar Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Liu, M.D, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495663
- Sponsor's protocol ID
- DCL-10-001
- Status last verified
- Feb 2015
- First submitted
- 16 Dec 2011
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects With Relapsed or Refractory Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01495663
- Acronym / sponsor ID
- DCL-10-001
- Conditions
- Cancer
- Keywords
- refractory, relapsed, non-small cell lung cancer, triple-negative breast cancer, soft tissue sarcoma, colorectal cancer, esophageal cancer, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cellectar Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase clinical development.
Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.
All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to injection of the dosimetric dose, and continuing for 14 days after the administration of the therapy dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Drug: I-131-CLR1404I-131-CLR1404 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Relapsed or refractory advanced solid malignancy or choice not to pursue standard treatment. Tumor types allowed: non-small cell lung, triple negative breast, soft tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian cancer
- ≥ 1 lesion that qualifies as a "target lesion" based on RECIST 1.1
- Ambulatory w/ECOG performance status 0 to 2 and estimated life expectancy ≥ 4 mo.
- 18 years or older
- Judged by Investigator to have initiative and means to be compliant with protocol and w/n geographical proximity to make required study visits
Key exclusion criteria (24 listed)
- Subject or physician plans concomitant chemotherapy, therapeutic radiation and/or biological treatment for cancer including immunotherapy while on study. Localized palliative radiation therapy for bone pain allowed if clinically indicated. Ongoing hormonal therapy may be continued
- Received > 3 previous cytotoxic chemotherapy regimens
- Received > 25% of total bone marrow irradiated, total body or hemi-body irradiation or prior radioisotope therapy (except for benign thyroid disease)
- Diffuse lung disease or interstitial spread of carcinoma
- Prior radiation therapy or chemotherapy w/n 4 weeks of study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-131-CLR1404Also: 18-(p-[I-131]-iodophenyl)octadecyl phosphocholineDescription: * Dosimetry: IV, 5 mCi, single dose, 6-day duration * Therapy: IV, starting dose level of 12.5 mCi/m2, single dose, 56-day duration with follow up to one year | Drug | Single Group |
Primary outcome
Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies
Time frame: Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)
Largest administered dose with at most a 20% dose limiting toxicity rate
4 secondary outcomes
Expansion of the safety profile of I-131-CLR1404
Time frame: Pre-infusion and 6 days after dosimetry infusion; weekly until 56 days after therapy infusion and then monthly for one year
Expansion of the pharmacokinetic profile of I-131-CLR1404
Time frame: Pre-infusion and 144 hours post-dosimetry infusion; pre-infusion, 5, 15, 60 minutes, 5, 24, 72 hours, 6, 14, 21, 28, 35, 42, 49 and 56 days post-therapy infusion
Preliminary antitumor activity of I-131-CLR1404
Time frame: Baseline at screening, 56 days post-therapy infusion, every 2 months in follow-up period up to one year
Tumor dosimetry of I-131-CLR1404 in a subset of subjects with non-hepatic lesions measuring at least 2 cm in one dimension
Time frame: 72 hours, 6, 14, and 21 days post-therapy infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Liu, M.D principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing I-131-CLR1404 in people with Cancer, run by Cellectar Biosciences, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies (time frame: Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.